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临床试验/NCT00769769
NCT00769769已完成3 期

Telephone CBT for Depressed African-American Dementia Caregivers

Robert L. Glueckauf2 个研究点 分布在 1 个国家目标入组 106 人开始时间: 2008年10月最近更新:
适应症

试验速览

阶段
3 期
状态
已完成
发起方
入组人数
106
试验地点
2
主要终点
Depression clinical diagnosis

研究概览

简要总结

This study will compare the effectiveness of face-to-face cognitive behavioral therapy versus telephone-based cognitive behavioral therapy for treating African Americans who care for family members with dementia.

详细描述

Approximately 4.5 million Americans suffer from progressive dementia, with higher rates among African Americans than among European Americans. The majority of caregivers for dementia patients are family members, who often deal with difficult behavior, agitation, and aggressiveness in the people for whom they care. Because of the challenges they face, family caregivers for dementia patients are at increased risk of mental health problems, particularly depression. Promising research has shown that cognitive behavioral therapy (CBT) can combat distress in African-American caregivers. One way to deliver CBT is through telephone-based interventions, which have been shown to lead to better psychological outcomes than routine education and support. This study will create treatment manuals for CBT tailored to the needs and preferences of African Americans who care for family members with dementia and will develop procedures and strategies for treatment delivery to and retention of members of this population. The study will then compare the effectiveness of face-to-face versus telephone-based CBT in improving mental health outcomes for African Americans who care for family members with dementia.

Participation in this study will last 3 months. Participants will be randomly assigned to receive either face-to-face or telephone-based CBT. Both groups will receive 12 weekly sessions of therapy targeting caregiver depression and social functioning over time. Before and after treatment, participants will be assessed on measures of depression and social functioning through standardized questionnaires given over the telephone. Additional data will be collected on social and demographic factors, stressors, caregiver appraisal of resources, and use and costs of both mental and physical health care.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Provides significant care for a spouse, parent, or relative who meets National Institute of Neurological and Communicative Disorders and Strokes-Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria for probable dementia
  • Provides care for a relative 60 years of age or older with progressive dementia
  • Primary informal care provider for the care recipient with dementia
  • Spends a minimum of 6 hours per week in providing direct care to the person with progressive dementia
  • Scores a minimum of 10 on the Patient Health Questionnaire-9 (PHQ-9)

排除标准

  • Endorses fewer than three problems on the depression and disruptive behaviors factors of the modified version of Revised Memory and Behavior Problem Checklist
  • Meets criteria for psychotic disorder on the Mini-International Neuropsychiatric Interview (MINI 5.0.0)
  • Meets criteria for moderate or high suicide risk on the MINI 5.0.0
  • Provides care for a dementia care recipient who has received a terminal diagnosis of 6 months, as defined by hospice care

结局指标

主要结局

Depression clinical diagnosis

时间窗: Measured before and after 3-month intervention

次要结局

  • Caregiver health status(Measured before and after 3-month intervention)

研究者

发起方
Robert L. Glueckauf
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Robert L. Glueckauf

Principal Investigator

Florida State University

研究点 (2)

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